1. Field of the Invention
This invention relates to methods of treating mental depression in humans.
2. Description of the Prior Art
Depression is used herein in accordance with the usage of the Text: The Medical Management of Depression, by Sir Denis Hill and Leo E. Hollister (and others), Medcom Inc., 1970.
In 1957, Dr. Ana Aslan reported in the German Medical Journal Therapiewoche, 1, 10 (1957), her work with geriatric patients and the beneficial results obtained on manifestations of aging, such as, depression, arthritis, angina pectoris and hypertension by treatment with an aqueous solution of procaine hydrochloride, benzoic acid, dipotassium metabisulfite and disodium phosphate. Specifically the aqueous solution was referred to as Gerovital H3 (GH3) which on a 5 ml. vial basis contained, in addition to water, procaine hydrochloride, 0.1000 g; benzoic acid, 0.0060 g; dipotassium metabisulfite, 0.0050 g; and disodium phosphate, 0.0005 g; typically this solution has a pH of 3.3. Or the same amount of recited (named) ingredients were mixed with excipients to form tablets (dragees) which tablets are taken by oral ingestion. The tablets are referred to as Gerovital H3 tablets.
Dr. Aslan has reported in numerous publications since 1958 that the GH3 formulation gave better results than procaine hydrochloride alone.
In a paper entitled "Theoretical and Practical Aspects of Chemotherapeutic Techniques in the Retardation of Aging Processes" presented at the Symposium on Theoretical Aspects of Aging, February 7-8, 1974 Miami, Fla., Dr. Aslan reviewed not only her work but also the work of others since 1945, especially in depression. She pointed out that preventive treatment should begin at about age 45. She states that in all her work: "we use a one month series of 12 injections of 1 vial of Gerovital H3 of 5 ml."; [i.e., 100 mg of procaine hydrochloride per injection.] A 10-day drug free interval -- pause or off-period-- is taken between each series of 12 injections.
The recommended treatment for tablets is: two tablets daily during 12 days (24 tablets in all); then a pause or off-period of 18 or 30 days before the next series of 12 days on tablets. [Gerovital H3, Chimimport, Bucharest, Romania.]
Allergic reactions to GH3 occur in about 1 out of 6,000 cases (Aslan, ibid). A test for allergy using GH3 solution: The first day one ml of GH3 solution is introduced by subcutaneous injection, and on the second day two ml are injected intramuscularly. If no allergic phenomena are recorded, the treatment may be started. A test for allergy using tablets: the first 2 days, only one tablet is taken; if no allergic phenomena are recorded the treatment may be started. [Gerovital H3, ibid.]